Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day.
Responsibilities:
- Assist in the preparation, review, and organization of regulatory documents such as submissions to regulatory agencies, reports, and correspondence.
- Conduct research on regulations, guidelines, and best practices relevant to the company's products or industry.
- Support the preparation and submission of regulatory filings, including new product applications, amendments, and periodic reports.
- Assist in communication with regulatory agencies, including responding to inquiries, requests for information, and notifications.
- Ensure that regulatory documents and processes adhere to company standards and regulatory requirements.
- Help maintain regulatory compliance tracking systems to monitor the status of regulatory submissions and approvals.
- Stay informed about changes in regulations, guidelines, and industry trends that may impact the company's products or regulatory strategy.
- Maintain regulatory documentation, including regulatory files, databases, and archives.
- Participate in training sessions to enhance understanding of regulatory requirements and processes.
- Contribute to special projects as assigned by regulatory affairs managers, which may involve process improvements, regulatory strategy development, or other initiatives.
Read Full Description